Home NDC 76451-018 Sodium Fluoride
Product NDC 76451-018
11-digit product format 764510018
Labeler code 76451
Product ID 76451-018_47d2e765-1b9b-343d-e063-6394a90aa8d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM FLUORIDE F-18
Dosage form INJECTION
Route INTRAVENOUS
Labeler 3D Imaging Drug Design and Development LLC
Application ANDA203777
Marketing category ANDA
Marketing start 2012-01-02
Substance SODIUM FLUORIDE F-18
Active strength 200 mCi/mL
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 64 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203777-001 SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203777-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203777-001 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE / INTRAVENOUS AP 2015-10-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sodium Fluoride
Brand name suffix F 18
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE F-18 200 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9L75099X6R Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76451-018-10 Sodium FluorideF 18 10 mL in 1 VIAL, GLASS INJECTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76451-018 SODIUM FLUORIDE F 18 (SODIUM FLUORIDE F-18) INJECTION [3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC] 1 Current NDC, Legacy NDC, 1 package rows 20190215_eeaf4f42-e3c6-4e0a-aa79-89722511eaea.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76451-018-10 76451001810 10 mL in 1 VIAL, GLASS (76451-018-10) 10 ml 2012-01-02 0000-00-00 No No Current 76451-018-11 76451001811 10 mL in 1 SYRINGE, PLASTIC (76451-018-11) 10 ml 2018-12-17 0000-00-00 No No Current 76451-018-51 76451001851 5 mL in 1 SYRINGE, PLASTIC (76451-018-51) 5 ml 2018-12-17 0000-00-00 No No Current